Health Condition 1: J849- Interstitial pulmonary disease, unspecified Health Condition 2: M348- Other forms of systemic sclerosis
Conditions
Interventions
Intervention1: Pulmonary Rehabilitation for 12 weeks: Breathing Exercise for 12 weeks
Control Intervention1: No Pulmonary rehabilitation for 12 weeks: No breathing exercise for 12 weeks
Sponsors
Dr Padmanabha Shenoy D
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged above 18 years and up to 70 years. Diagnosed with systemic sclerosis (scleroderma) based on ACR EULAR 2013 classification criteria, with high-resolution computed tomography (HRCT)-proven interstitial lung disease (ILD). Clinically stable patients at the time of recruitment. Patients able to perform the 6-minute walk test (6MWT) and maintain an oxygen saturation during the test without supplemental oxygen.
Exclusion criteria
Exclusion criteria: Patients with severe pulmonary arterial hypertension (PAH) defined as estimated pulmonary artery systolic pressure(PASP)60 mm Hg or a peak tricuspid regurgitant velocity (TRV 3.4 ms)(Ref AHA LVOT , recent myocardial infarction (MI), unstable angina, or a documented history of significant cardiac arrhythmias in last 3 months Patients with modified Medical Research Council (mMRC) grade 4 dyspnea. History of acute exacerbation of ILD within the past 3 months. Patients unable to ambulate independently. Presence of neurological or musculoskeletal conditions that impair mobility or limit the performance of gentle exercise. exercise desaturation Recent MI or unstable angina or history of arryhthmias ( in the last 3months ) FVC less than 30 percent of the predicted
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function, measured by spirometry. Health-related quality of life (HRQoL), assessed using the St. George s Respiratory Questionnaire (SGRQ), Chronic Respiratory Disease Questionnaire (CRDQ), and Hospital Anxiety and Depression Scale (HADS). Breathlessness, evaluated using the modified Medical Research Council (mMRC) dyspnea scale. Fatigue, measured by the Visual Analogue Scale (VAS). Timepoint: Baseline , 6 weeks and 12 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| oTo evaluate the effect of conventional drug therapy in combination with a 12-week home-based pulmonary rehabilitation (PR) program on the 6-minute walk test (6MWT) performance capacity of patients with systemic sclerosis associated interstitial lung disease (SSc-ILD), as compared to conventional drug therapy alone.Timepoint: baseline 4 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Tony K S
Dr Shenoy s Care Private Limited
Outcome results
None listed